ImmunityBio announced on October 14, 2026, that the U.S. Food and Drug Administration (FDA) has expanded the approved indication for its drug, ANKTIVA®, used in combination with BCG. The approval now includes the treatment of patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with papillary-only tumors, significantly increasing the drug's addressable patient population.

Key Details

  • Product & Approval: Expanded FDA approval for ANKTIVA® (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG).
  • Expanded Indication: The treatment is now approved for adult patients with BCG-unresponsive NMIBC with papillary-only tumors. This is reportedly the first FDA approval for this specific patient group.
  • Market Impact: This new indication significantly broadens the drug's U.S. addressable market, as papillary disease represents approximately 85% of the NMIBC patient population. The drug was previously approved in April 2024 for NMIBC with carcinoma in situ (CIS).